Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
Fogarty International Center (FIC) (http://www.fic.nih.gov)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)
National Cancer Institute (NCI) (http://www.nci.nih.gov)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov)
Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/)

Title: Millennium Promise Awards: Non-communicable Chronic Diseases Research Training Program (NCoD) (D43)

Announcement Type

New

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-08-175  

Catalog of Federal Domestic Assistance Number(s)
93.989. 93.865, 93.853,  93.894,  93.361, 93.393

Key Dates
Release Date: June 12, 2008
Letters of Intent Receipt Date(s): August 31, 2008; August 31, 2009; August 31, 2010  
Application Receipt Dates(s):September 29, 2008; September 29, 2009; September 28, 2010
Peer Review Date(s): January/March 2009, January/March 2010; January/March 2011
Council Review Date(s): May 2009; May 2010; May 2011  
Earliest Anticipated Start Date: July 2009; July 2010; July 2011     
Additional Information To Be Available Date (URL Activation Date):
Expiration Date: September 29, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

This research training program is designed to build research capacity in low- and middle-income countries (LMICs) in the fields related to cancer, cerebrovascular disease including stroke, lung disease including chronic obstructive pulmonary disease (COPD)  and environmental factors including indoor air pollution, and obesity and lifestyle factors related to these conditions as well as genetics of non-communicable diseases. The institutions applying can be domestic or foreign, but have to exhibit the ability to do such training, and must exhibit that they have existing research programs in these fields.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Training Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing   
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Training Objectives

This is a funding opportunity announcement for a research training program related to chronic, non-communicable diseases to help build capacity for future local research in LMICs.  This responds to a number of goals in the new FIC strategic plan (http://www.fic.nih.gov/about/plan/strategicplan_08-12.htm). 

The research areas include cancer, cerebrovascular disease including stroke, lung disease including chronic obstructive pulmonary disease (COPD), obesity as well as genetics, environmental factors including indoor air pollution, and lifestyle factors related to these conditions. The research that these trainees would be associated with is expected to be of importance in the participating LMICs.

Burden of Disease

Chronic non-communicable diseases are steadily increasing around the world and in LMICs, which will soon account for more than 50% of the expenditures for health care and more than 50% of the disability adjusted life years (DALYs).  According to the Disease Control Priorities Project and World Health Organization (WHO), 44% of adult disease burden in LMICs is now attributable to non-communicable diseases and is projected to increase to 54% by 2030.  The proposed “Grand Challenges in Chronic Non-Communicable Diseases,” developed through an extensive international consensus process, clearly shows the imperative to address these problems now. (Daar AS, et al., Nature, 450 (22 Nov 2007): 494-496.)  As the origin of and potential solutions to most chronic diseases are complex in nature, programs that strive to develop and provide training across disciplines (e.g., bridging biological, social, and behavioral sciences) are strongly encouraged.

In addition to generating evidence to prevent and treat chronic diseases, it is imperative that the research findings be incorporated into community practice in an efficient and timely manner.  In fact, we face a formidable gap between innovations in health (including vaccines, drug discovery and strategies for care) and their delivery to communities in LMICs (Madon T, Hofman KJ, Kupfer L, Glass RI.  Public Health. Implementation Science.  Science. 2007 Dec 14;318(5857):1728-9).  Training researchers in the nascent field of implementation and dissemination science would be appropriate under this announcement. 

Risk factors for chronic non-communicable disease are complex. Many of the key important risk factors are the social determinants like physical inactivity, poor diet, tobacco smoking and factors which lead to obesity.

However, the interactions between genetic and environmental risk factors are critical in the ontogeny of many non-communicable diseases.

Furthermore, it is critical to develop a deeper understanding of the complex motivations that contribute to risky behavior in a resource poor setting. These factors can have a profound effect on how risk factors are perceived and incorporated into people’s decision making processes and ultimately their behavior.

According to WHO’s estimation, death from stroke each year in LMICs accounted for more than 85% of stroke death world-wide. The number of DALYs caused by stroke in LMICs was also seven times higher than the number in high-income countries (HICs).  The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting research training in mechanistic, epidemiological, prevention, translational and clinical research in the areas of stroke.

Lung disease due to cigarette smoke (direct or indirect) or especially indoor air pollution at work or at home is rapidly increasing in both adults and children.  WHO estimates by 2030, COPD will be among the four leading causes of death globally (http://www.who.int/whosis/whostat2007_10highlights.pdf).  According to WHO estimates, 210 million people currently have COPD, more than 3 million people died of COPD in 2005, corresponding to 5% of all deaths globally, and almost 90% of COPD deaths occur in LMICs (http://www.who.int/mediacentre/factsheets/fs315/en/).

Obesity is becoming a major component of the healthcare landscape in developing countries, even in countries where under nutrition is simultaneously present sometime even in the same family. According to WHO, 2.3 billion adults (age ≥ 15 years) will be overweight and 700 million will be obese worldwide by 2015.  In 2005, over 20 million children (< 5 years) were overweight globally.  Overweight and obesity are risk factors for many chronic diseases that affect the quality of life and lead to premature mortality. Obesity, can for example, lead to hypertension, Type II diabetes, osteoarthritis, stroke, gall bladder disease, cancer and coronary artery disease.

Cancer is becoming more common, due at least in part to aging populations. More than 70% of all cancer deaths occur in LMICs, where resources available for prevention, diagnosis and treatment of cancer are limited or nonexistent.  Based on projections, cancer deaths will continue to rise with an estimated 9 million people dying from cancer in 2015, and 11.4 million dying from cancer in 2030 (http://www.who.int/cancer/en/).

The bulk of factors that are responsible for onset of the chronic disease are so diverse that it is essential that those trained in these areas of research have broad understanding or work across disciplines that might include nutrition, business and the corporate sector, behavioral health, health law, economics, environmental health and urban planning. Most of the research training and research on chronic diseases has been conducted in HICs and it has seldom been multidisciplinary. This program is therefore intended to strengthen research capacity by developing a pipeline of scientists in LMICs who will conduct transdisciplinary and implementation research in this field.

 In order to develop the research capacity to carry out scientific research on these and other topics related to chronic, non-communicable diseases, the Fogarty International Center has developed this particular FOA for this research training program.

Each research training program application could incorporate an appropriate mix of long-, intermediate- and short-term training opportunities in a wide range of relevant disciplines and skills necessary to advance the study of chronic diseases.  It is expected that the proposed training would strengthen sustainable research and core research support capacity at the foreign site and could include advanced in-country research at the end of training.  Training may take place at the U.S. or foreign sites and training-related research should be carried out mainly in the country of the foreign institution(s).  Training is encouraged to take place at the foreign site. While a range of short-, intermediate- and long-term training is allowable, emphasis will be on intermediate- to longer-term training, including mid-career training.  In the context of this FOA, “trainees” are scientists from the LMIC country identified in the application.

The following types of training could be included:

When a specific scientific course is given by one training program, it is expected and encouraged that this course be widely publicized and open to trainees of the other grantee institutions under this program.

This research training program strongly encourages principal investigators (PIs) to include women and individuals from underrepresented racial, ethnic or socially disadvantaged groups in the  LMICs as trainees and faculty at all sites.

LMIC institutions in collaboration with a HIC institution may apply for a two-year planning grants to support the development and submission of research training program proposals in the subsequent year.  

See Section III.3 “Other Special Eligibility Criteria” for additional details.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity announcement (FOA) will use the D43 research training program award mechanism.  The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

This program does not use the Modular budget format.  You must include detailed budget information.

The estimated amount of funds available for support of 7 full awards and one to two planning grants initially awarded as a result of this announcement is $1,500,000 for FY 2009. Future year amounts will depend on annual appropriations.

Planning Grants for Developing Country Institutions:

LMIC institutions in collaboration with a HIC institution may apply for a two-year planning grant to develop a future chronic disease research training program with U.S. collaborators. Planning grants should propose the following types of activities to organize and plan for a research-training program, and prepare and assemble an application to submit for support of that program the following year:

Because the nature and scope of the proposed research training will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Public/State Controlled Institutions of Higher Education in the U.S. with collaborating partners in LMICs; Private Institutions of Higher Education in the U.S. with partners in LMICs and Non-domestic (non-U.S.) Entities (Foreign Organizations) in LMIC’s in collaboration with U.S. Institutions are also invited to apply

Both U.S. and Foreign research institutions that have the infrastructure to train researchers in master’s or doctoral level work are eligible and must have demonstrable ability to do such research training. 

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research training program as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model.  Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

For applications from HICs collaborating with LMICs, the use of the multiple PI/PD initiative is encouraged with the major foreign collaboration in each country.

The U.S. PI or the foreign PI applicant should have a doctoral-level degree.  If they do not possess a doctoral-level degree, an explanation for an exception must be provided in the application.

The applicant must have strong chronic non-communicable disease research and research-training program experience, and the requisite faculty and facilities to carry out the proposed research training activities.  The PI and/or key personnel listed on the application must be designated as the PI of at least one active (with at least 18 months of support remaining at the time of application) chronic, non-communicable disease-related research award, directly relevant to the research training proposed and, within 2 years of the award from this program, at least a portion of that research must be performed at the foreign site.  The research grants may be funded by the NIH or by other national or international organizations or foundations.   The applicant must have ongoing research in the area of science described in the application and some existing collaboration with the foreign site which can be of an educational nature.

The PIs must hold faculty or other long-term research positions at a public or private non-profit research institution that will allow them adequate time and provide appropriate facilities, salary support and resources, including access to patients or patient data, when necessary. Priority will be given to applicants associated with NIH-funded direct research grants to the foreign institution(s) or with NIH-funded research grants with foreign components at the foreign institution(s). Women and individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are encouraged to apply for this program.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Any given institution may submit only one application per year.

Any given applicant may receive only one award over the lifetime of the FOA.

Applicants may submit a resubmission application in response to this program, but such application must include an Introduction addressing the previous peer review critique (Summary Statement).

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-008

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Foreign Organizations [Non-domestic (non-U.S.) Entity]

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): August 31, 2008; August 31, 2009; August 31, 2010  
Application Receipt Dates(s): September 29, 2008; September 29, 2009; September 28, 2010
Peer Review Date(s): January/March 2009, January/March 2010; January/March 2011
Council Review Date(s): May 2009; May 2010; May 2011  
Earliest Anticipated Start Date: July 2009; July 2010; July 2011           

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Aron Primack, MD, MA
Division of International Training and Research
Fogarty International Center 31 Center Drive
Building 31, Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 496-4596
FAX:  301-402-0779
Email:  primacka@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix materials must be sent to:

Aron Primack, MD, MA
Fogarty International Center
National Institutes of Health
Bldg 31, Room B2C39
31 Center Drive
Bethesda, MD 20892-2220
Telephone: (301) 496-4596
Fax:  (301) 402-0779
Email: aron_primack@nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt/ date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

Detailed Budget for Initial Budget Period

Use the following instructions for preparing Budget:

Develop a budget that reflects the resources necessary to implement the components of the comprehensive research-training plan included in your application.  The budgets may include costs to support the various types of research training proposed for trainees (tuition/fees, stipends, and travel) and faculty (salary, per diem costs at the foreign site), and costs to support the administration of the program. 

Provide a detailed budget justification explaining how requested funds will primarily support LMIC trainees. LMICs are defined through the World Bank website and can be found at http://www.worldbank.org/data/countryclass/classgroups.htm).  All expenses related to trainee participation in the program should be itemized on the PHS Form 398 (NRSA substitute budget pages 4 & 5) in the appropriate categories.  All expenses related to faculty participation in the program should be itemized on the PHS Form 398 (budget form pages 4 & 5) in the appropriate categories.  The total direct costs of the trainee participation budget should be identified on PHS Form 398 (budget form pages 4 & 5) in the "Other" category.  The combining of the budget figures will allow reviewers and FIC staff to review a composite budget of all costs.

Faculty Participation (budget form page 4)

Requested Salary Support:  The salary for the PI, other training faculty and administrative staff must be commensurate with the salary structure and benefits at the institution where they are employed and within the limits described at  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-051.html.  Foreign collaborators may receive appropriate compensation for their significant activities on the program, such as recruitment and selection activities, as well as other program-related roles.  The administrative, training or teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described and justified.  The salary and fringe benefits for the PIs and staff in total should not exceed 30 percent of total direct costs.

Faculty Travel:  Funds may be requested for round-trip economy airfare on U.S. carriers (to the maximum extent possible) and lodging and per diem for U.S. faculty providing training at the foreign site.

Network Meetings:  There will be an annual program network meeting to coordinate program activities, normally in the U.S., for which the applicant should budget.  Principal Investigators are expected to attend.  Applicants may also budget for grant administrators, other faculty, collaborators and trainees to attend.  The attendance of trainees is particularly encouraged.

Trainee Participation (NRSA substitute budget form page 4)

Trainee Stipends:  Trainees may be paid a stipend comparable to their professional experience in accordance with NRSA levels or grantee institutional policies while involved in medium- or long-term training at the grantee institution.  Current NRSA stipend levels may be used as a guide and are described at http://grants.nih.gov/training/nrsa.htm.

Note that health insurance is not included as part of this budget category. See the Training Related Expenses category below.

Funds for tuition and academic fees at the U.S. or foreign institution may be requested.  Programs are encouraged to seek cost-sharing arrangements with the grantee institutions in order to provide reduced tuition for trainees.

Trainee Travel:  Funds may be requested for round-trip economy class airfare on U.S. carriers (to the maximum extent possible).  Funds may be requested for lodging and per diem for short-term trainees.

Training Related Expenses:  Funds may be requested for one-time advanced in-country research support of up to $15,000 total costs for mentored research to be undertaken by a long-term trainee in his/her country upon completion of their training.  Applicants are encouraged to budget for adequate professional development (including, but not limited to, international scientific conference attendance) opportunities for trainees.  Training-related expenses (books, computers, and courses for software, English language proficiency, etc.) may be included but must be described in the budget justification.  Funds for self-only or family medical insurance may be requested, as long as the same insurance allowance is provided to other individuals in similar training positions at the sponsoring institution.

Tuition and Fees:  Funds for tuition and academic fees at the U.S. or foreign institution may be requested.  Programs are encouraged to seek cost-sharing arrangements with the grantee institutions in order to provide reduced tuition for trainees.

Budget for Entire Proposed Period of Support

Use the Institutional Training Grant Substitute Form Page 5 for the trainee expenses and PHS Form 398 Budget form page 5 for administrative and faculty expenses and for the aggregated total direct costs for the trainee expenses.

Biographical Sketch

Include biographical sketches for the Program Director(s) and Other Senior/key Personnel contributing to the training program. This will include “Collaborators” and Training Advisory Group (TAG) members. Do not include bio-sketches for mentors as they are attached at 8.9.13 as Participating Faculty

All Program Director(s) must be registered in the eRA Commons and must include the assigned Commons User ID.  Collaborators and key personnel should also be registered in the eRA Commons if they are to review correspondence and comments.

Resources

Resources pages should be completed for all performance sites. Pertinent research resources and the educational environment including the options, if relevant,  available for distance learning for the proposed training at the U.S. and partner country institutions should be described.  Creative and innovative use of Information Technology related to the disease study and/or prevention is encouraged. 

Research Training Program Plan

Introduction (Resubmission or Revision Applications Only)

An unsuccessful application may only be re-submitted in response to a FOA for this chronic, non-communicable research training Program. 

Note: Twenty-five page limit for Sections 8.9.2-8.9.5

Follow these directions for Sections 8.9.2-8.9.4:

Section 8.9.2 Background

The proposed research-training program may focus on one or more chronic disease and the associated life-style behavior-impacted diseases (e.g. oncologic, pulmonary diseases) of major health importance to the population in the proposed LMIC(s).

The research training should be developed related to a need in the LMIC institutions.  Explain the relevance of the chronic disease focus of the proposed training to the health of the host country and to the overall institutional development plan of the foreign site(s).

Describe the background of the research and training collaborations between the key personnel at the applicant institution(s) and the proposed partner institution(s).

Identify areas of mutual interest between LMIC institutions and any co-sponsoring NIH Institutes, Centers or Offices identified on the FOA.

Do not complete Tables 1 and 3. See 8.9.3 Program faculty for instructions for Table 2 Participating Faculty Members.

Section 8.9.3 Program Plan

A.  Program Administration. Describe the PD/PI’s qualifications for providing leadership of the program, including relevant scientific background, current research areas, and experience in research training. Indicate the Program Director's percent effort in the proposed program.

Describe the administrative structure of the program and the distribution of responsibilities within it, including the means by which the program director will obtain continuing advice with respect to the operation of the program.

If more than one foreign site will participate in the program, provide a justification for the inclusion of multiple sites within the framework of budget constraints and the goal of developing institutional research capacity, for example because the number of available qualified trainees may be insufficient at one institution or to integrate training across a network linked through a multi-site research activity.  Multiple foreign sites may also be required to collectively provide the necessary faculty expertise or infrastructure for a quality, comprehensive research training program in a particular chronic disease area.

Describe how the proposed research training and capacity building supports the research priorities of the country of the foreign institution.  Include a description of the procedures to assure this takes place within the context of the collaborative relationship, including input from scientific and community advisory boards in the foreign country.

This program cannot be used as the primary support for clinical trials but could be used to fund training programs related to such clinical trials provided appropriate safeguards including Federal Wide Assurances, Institutional Review Boards or International Ethics Committees are duly constituted, and Data and Safety Monitoring Boards (DSMBs) are in place.

Training Advisory Group (TAG):  Describe the composition and expertise of a TAG composed of expert faculty from the U.S. and the proposed LMICs who are not directly involved in mentoring trainees. The TAG assists in trainee selection, scientific peer review of trainee projects, and evaluation of trainees and training program progress.

Describe in detail the internal peer review process that will be used for training-related and advanced in-country research.

B.  Program Faculty.

Describe the roles, responsibilities and commitments from the senior/key personnel from the U.S. and partner country institution(s). State what these individuals would actually do and their time commitments to the program.

Include a list of the other potential mentors and their scientific areas of interest at the applicant institutions in Table 2 and include bio-sketches in 8.9.13. Include a summary of the training and mentoring experience of the faculty in training pre-doctoral and post-doctoral trainees particularly trainees from LMI countries, with special mention of trainees from the country focus of the proposed program.

Include letters from senior/key personnel and participating faculty defining their specific roles (such as mentoring and teaching) and time commitments in the proposed training program in 8.9.15. 

In Table 4, include a list of the research grants in which the PD/PIs, key faculty at the foreign institution or relevant faculty at the partner institution have played a key role. Please include source of support and grant number (if applicable), grant title, project period and current year direct costs. Include PI if not the faculty member and role played by faculty member with Grant Title. Include Institution with faculty member name.

Provide a short description of the funded research in Table 4 and any other currently funded and future research that will serve as the research base for the proposed research-training program.

Do not complete Table 5

C.  Proposed Training. 

Use these instructions for the Section C. Proposed Training.

Describe the proposed research training program, including the goals, objectives and plan for meeting the objectives for this PA.  A description of the plans for the integration of research capacity building activities at the LMIC institution(s) should be included.

Describe how resources from this award will be integrated with other research or research training resources at the LMIC institution(s) or within the LMIC’s to achieve the overall goals of this program: building sustainable research capacity at the LMIC institution(s).

Describe plans for dissemination of training materials, as well as other coordination efforts, to other FIC research training programs in LMICs.

Describe how the proposed research training program may serve as a bridge among academic research, policy makers and public health communities to help to link the various research areas with the programs supported in the country by NIH and other sponsors.

Describe an appropriate balance of research training options (degree-related and non-degree training) to match the needs of the trainees and their LMIC institution. Long-term (> 6 months) research training may include studies leading to an advanced degree or a mentored post-advanced degree experience. Short-term training involving short courses, workshops or practical experience of up to several months in specific research methods or other laboratory, clinical, epidemiological, preventive care, transdisciplinary, social science or field skills for research may be proposed in addition to long-term training. Participants in short-term training must be involved in research in which the training will be immediately utilized at partner country institution(s). Didactic short courses or workshops on broad scientific or medical topics not directly relevant to the research training focus of the program will not be supported.

Training and trainee degrees may be attained at either the U.S. or foreign country institution. However, applicants are strongly encouraged to provide support and mentoring by U.S. and partner country faculty for trainees to conduct the research related to their training in the partner country to the greatest extent possible.

Mentored trainee research may focus on basic sciences to understanding mechanism of diseases, behavior or pathology or to develop new interventions, prevention measures or diagnostic methods, as well as clinical, operational, health services and implementation science studies. Trainee research projects may be part of a training faculty member's peer-reviewed research grant funded by NIH or other research support agencies. 

All training-related research projects in which trainees are involved under this award must be independently peer-reviewed through scientific review procedures established by the applicant institution, and have written evidence of documentation of education in the protection of human subjects for the trainee (see 8.9.5), compliance with the required federal citations, and approval from an institutional (or ethical) review board or committee at both the U.S. and foreign institutions and from the relevant government authority.  Please see:  Procedures for Registering Institutional Review Boards and Filing Federal-Wide Assurances of Protection for Human Subjects (FWAs) at http://www.hhs.gov/ohrp/assurances/assurances_index.html.

Applicants should also provide training in adjunct skills needed at the partner country institution(s) to support sustainable independent research such as the use of scientific literature, scientific writing and presentation, grant writing, bioinformatics, bioethics, good clinical practice, biosafety, data management, research administration, the management of intellectual property and English as a second language, if necessary.

Describe plans to include education in the inclusion of children, women and individuals from underrepresented racial, ethnic and disenfranchised groups in research in their country.  Where appropriate, the design of training-related research projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed.  These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies. 

Applicants are required to provide all long-term trainees with training in the responsible conduct of research at either the U.S. or developing country institution. For more information on this provision, see the NIH Guide for Grant and Contracts (volume 21, number 43 http://grants.nih.gov/grants/guide/notice-files/not92-236.html). NIH does not require a specific curriculum or format for instruction but the following areas should be included: conflict of interest, responsible authorship and institutional policies for handling scientific misconduct, human subjects, animal studies, data management and data sharing. The inclusion of international perspectives on these topics is strongly encouraged. The following information must be provided in the description of your plan: topics to be covered, format, faculty participating, instructional materials, frequency and duration of training, and how trainee attendance will be monitored.

D.  Training Program Evaluation.

Awardees will be required to track and document the long-term impact of this training program on the research capacity of the foreign institution(s) including the impact on the career of the trainees.

Describe a plan for self-evaluation of the program.  Once it is available, all grantees will be required to use Careertrac, provided by FIC, to track long- and medium- term trainees during and after their training.  To determine the impact of training on their subsequent careers, grantees are encouraged to use this tool to continue to track these students for at least five years after completion of their training.   Until the tool is available, grantees will be required to keep track of their trainees through training and five years after using their own systems.

Success of the trainees can be measured by the number and quality of publications, presentations, courses developed, professional awards, grant funding, career advancement and subsequent employment that demonstrates their sustained commitment to research careers in their home countries; their contributions to future international research collaborations and research training; their influence on the development and use of research findings in their countries; and their ability to act as consultants, teachers, collaborators and role models to other local investigators and further disseminate the lessons learned. 

Evaluation metrics should eventually encompass both the success of the individual trainees and the impact of the program on research capacity at the foreign institution(s).  An evaluation of the impact of training supported by the grant will be considered an important criterion during any re-competition of this PA.  Applicants should establish some benchmarks and a mechanism to periodically review the progress of the trainees and the effectiveness of the program.  This may consist of regular meetings among faculty participating in the program and periodic review by the TAG and other outside consultants.

E.  Trainee Candidates.

Describe recruitment plans, including the sources and availability of trainees; the qualifications of prospective trainees; and the criteria and procedures by which trainees will be selected.

Use these instructions for Section E. Trainee Candidates

Training plans should also describe in detail each of the following processes:

Describe the characteristics of the trainees you plan to recruit for each type of training proposed. Training may be offered to a wide range of scientists, including laboratory scientists, clinicians, social scientists, and other health professionals, as well as technical and administrative staff. The intent of all training proposed should be to build a critical mass of researchers and support staff with the combined expertise and skills to conduct research.

Provide a detailed description of the recruitment and selection procedures and criteria for the foreign doctoral and post-doctoral scientists and other beneficiaries of the research training program (short term trainees, workshop participants, etc). The TAG should be included in this process.  Criteria should include a list of standards that will be used to ensure that trainees have appropriate prior training and experience, are likely to complete the program, and are likely to develop into productive independent researchers.  The recruitment and selection process must be transparent and widely advertised within the appropriate countries.

Degree candidates must meet all entrance requirements of the U.S. or foreign degree-granting institution.  Thought should also be given to preparation of non-degree long-term trainees in English language and/or computer skills in the summer preceding studies in the U.S. or at the foreign site, where appropriate, to allow them to make optimal use of their formal training period.  Fees for such courses are allowable costs.

Applicants should describe strategies for recruiting and retaining women and socially and economically disadvantaged persons as trainees.  Applications must identify a major role of the partner institutions in the recruitment and selection plan.

This plan should include procedures for retaining students in the research training program until completion. 

Describe strategies to encourage trainees to remain in or return to their home countries after completion of their training. 

Describe plans to encourage and provide support to trainees to apply for awards under the Global Health Research Initiative Program for New Foreign Investigators (see http://www.fic.nih.gov/programs/research_grants/grip/index.htm), the Fogarty International Research Collaboration Award (see http://www.fic.nih.gov/programs/research_grants/firca/index.htm)(non HIV)   and other relevant research grants. 

Do not complete Tables 7A, 7B, 8A, 8B, 9A and 9B.

Section 8.9.4 Recruitment and Retention Plan to Enhance Diversity

Discuss plans to promote diversity relevant to the proposed LMICs, rather than those defined within the U.S. context.  Do not complete Tables 10.

Section 8.9.7 Human Subjects

Applicants should describe plans to meet the requirements related to the protection of human subjects in all training-related research.  All non-degree training-related research projects in which trainees are involved under this award must be peer-reviewed through the TAG.  It is assumed that all degree-related research receives peer review through standard institutional mechanisms. All trainees involved in human subjects research need documented evidence for education in the protection of human subjects for the trainee, compliance with the required federal citations, and approval from institutional (or ethical) review boards or committees at applicant and collaborating foreign institutions, and from the relevant government authority. 

Follow PHS 398 instructions for

8.9.8    Vertebrate Animals

8.9.9    Select Agent Research

8.9.10  Literature Cited

8.9.11  Multiple PD Leadership Plan

8.9.12  Consortium/Contractual Arrangements

8.9.13  Participating Faculty Biosketches

8.9.14  Data Tables- Attach all Data Tables (1-12B) but complete only  Tables 2 and 4 for all applications and complete Tables 6, 12A and 12B for renewal applications.

6. Other Submission Requirements and Information

Appendix Materials

All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application.  Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs for funding consideration on the basis of established PHS referral guidelines.

As part of the scientific peer review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications.

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The goals of NIH supported research training are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research training will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance:  Does this research training program address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of this program on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

Approach:   Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs? 

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? 

Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? 

Environment:  Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Does the proposed training benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? 

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Resubmission Applications (formerly “revised/amended” applications Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Training in Protection of Human Subjects from Research Risk: The plans for training regarding the involvement of human subjects and protections from research risk relating to their participation in the proposed trainee research will be assessed (see the Research Training Plan section on Human Subjects in the PHS 398 instructions).

Training in Inclusion of Women, Minorities and Children in Research: The adequacy of training plans regarding the inclusion of subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the trainee research will be assessed if involved in proposed trainee research.

Training in Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the trainee projects, plans for training in care and use of animals in research will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Training in the Responsible Conduct of Research:

We expect all applicants and key personnel to exhibit appropriate training in the responsible conduct of research as a just-in-time requirement.

Programs must have appropriate mechanisms in place to capture trainee demographic data.

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed. 

2.C. Resource Sharing Plan(s)   

The following resource sharing policies do not apply to this FOA:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Aron Primack, MD, MA
Fogarty International Center
National Institutes of Health
Bldg 31, Room B2C39
31 Center Drive
Bethesda, MD 20892-2220
Telephone:  (301) 496-4596
Fax:     (301) 402-0779
Email: aron_primack@nih.gov

2. Peer Review Contacts:

Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
6701 Rockledge Drive, Room 5136, MSC 7840
Bethesda, MD  20892-7840
(For express/courier service use ZIP 20817)
Telephone:  (301) 435-1021
Fax: (301) 480-3567
Email: duperes@csr.nih.gov

3. Financial or Grants Management Contacts:

Elizabeth Cleveland
Grants Management Specialist
Fogarty International Center
Building 31, Room B2C29
Street Address:  31 Center Drive 
Bethesda, MD 20892
Telephone: (301) 451-6830
FAX: (301) 594-1211  
Email: clevelande@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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Bethesda, Maryland 20892 		  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) 		  USA.gov - Government Made Easy

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